# K083869: BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S)  Dddiii BTICV3, 1, and Dddiiibtisi

- Pathway: 510(k) (Abbreviated)
- Applicant: Btlock Srl
- Decided: Mar 27, 2009 after 88 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K925765 (1993). 91 ancestors in all.
No later device cites it as a predicate yet.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073458: BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2), Btlock Srl (2008) Summary page 2.
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 4.
- K031345: Nobel Direct, Models 30937, 30938, Nobel Biocare Uas, Inc. (2003) Summary page 5.
- K052471: HDC Spider Screw, Hdc S.R.L. (2005) Summary page 6.

## Indications for use
BT-Tite CV3: It is intended to be used in maxilla or mandible, for post-extraction sites and where the implant would be immediately loaded. It is intended to be used in a single stage or two stage surgical procedure. Mini Implant: It is intended to be used in maxilla or mandible for immediate and long-term stabilization of removable prosthesis. Mini Single: It is intended to be used in maxilla or mandible in anterior narrow sites of dental arch, to replace lateral teeth, dental agenesis and inferior incisors. Slot implant: It is intended to be used as temporary intra-oral anchorage unit in the orthodontic treatment in the superior or inferior arch or extra arch in case of edentulous patients, when necessary teeth for the anchorage are absent or the next teeth are compromised from a parodontal point of view. It facilitates the orthodontic movement of teeth. It is removed after orthodontic treatment has been completed. Slot implants are intended for single use only.

Source page: https://510kreport.com/device/K083869
Methodology: https://510kreport.com/methodology